Unlocking Brazil’s Medical Device Market: Inmetro Certification Guide 2025

Brazil continues to stand out as one of the fastest-growing markets for medical devices in Latin America. With major healthcare reforms, increased public investment, and a shift toward advanced medical technologies, Brazil’s medical device market is becoming a key focus area for global manufacturers.

Successfully launch medical devices in Brazil, understanding the in-metro certification process is critical. This regulatory requirement ensures that medical devices meet Brazilian safety, quality, and performance standards before commercialized.

Brazil’s Booming Healthcare Market in 2025

Driven by post-pandemic healthcare innovation, Brazil’s medical device imports and demand continue to surge.
 Key drivers include:

• Increased investment in hospital infrastructure and telemedicine
• Expansion of public health programs
• Rising demand for home healthcare and diagnostic devices
• Strong focus on innovation and technology integration

These trends make regulatory compliance in Brazil a strategic priority for international manufacturers seeking long-term market access.

What Is Inmetro Certification?

Inmetro (National Institute of Metrology, Quality and Technology) oversees the conformity assessment for devices that fall under Brazil’s technical regulations.
 For medical devices, inmetro certification typically follows Model 5, which includes:

• Type testing of representative device samples
• Quality Management System (QMS) evaluation based on ISO 13485 or ISO 14971
• Factory audits conducted at intervals not exceeding 15 months

While inmetro certification validates product safety and performance, Anvisa approval is required to authorize product commercialization in Brazil.

Leveraging ILAC-Accredited Testing

International manufacturers can leverage ILAC (International Laboratory Accreditation Cooperation) agreements to simplify the certification process.
 If product testing performed in an ILAC-accredited laboratory, the data may be accepted by Inmetro — eliminating redundant testing in Brazil.

Key Benefits:

• Faster certification timelines
• Reduced testing costs
• Global recognition of test data
• Simplified path to market entry

This approach aligns with global harmonization efforts and supports smoother entry into Brazil has regulated medical device sector.

Required Documentation for Inmetro Certification

Manufacturers must prepare a complete technical dossier in accordance with Inmetro and Anvisa requirements, including:

• ISO 13485 / ISO 14971 certificates and QMS records
• Design history files and risk management reports
• Routine production test procedures
• Technical documentation and product manuals (translated into Portuguese)
• Local and factory audit schedules
• Evidence of conformity to electrical and safety standards

All documents must meet Brazilian regulatory expectations, ensuring accuracy and completeness during audits.

Cybersecurity & Compliance: 2025 Regulatory Focus

In 2025, cybersecurity compliance has become a key consideration in the Brazilian medical device regulatory framework.

Manufacturers must demonstrate that:

• Secure software lifecycle practices are implemented
• Risk assessments for network-connected components are completed
• Post-market surveillance includes monitoring cybersecurity incidents
• Traceability systems protect device software and data integrity

Cybersecurity readiness directly linked to regulatory approval timelines and can influence Anvisa’s acceptance of new medical devices in Brazil.

Timelines and Certification Process Overview

The Inmetro certification process generally follows a structured timeline:

1. Document Review & Application Submission – Manufacturer submits complete documentation and test data.
2. Sample Evaluation & Type Testing – Conducted in accredited labs or via ILAC-recognized data.
3. Factory Audit – Verification of production and quality systems.
4. Certificate Issuance – Typically within 90 days, depending on device complexity.
5. Ongoing Surveillance Audits – Every 15 months for continued compliance.

Note: The Inmetro certificate has no expiration date but requires consistent maintenance through surveillance audits.

Strategic Insights for 2025: Key Compliance Challenges

Manufacturers often face these challenges when entering the Brazilian market:

To overcome these, companies must adopt a robust regulatory strategy, maintain continuous compliance, and ensure accurate localization of documentation.

Maven Regulatory Solutions: You’re Partner in Brazil Market Access

At Maven Regulatory Solutions, we empower medical device manufacturers to navigate Brazil’s regulatory ecosystem with confidence and efficiency.

Our expertise includes:

• Inmetro and Anvisa submission management
• Technical documentation preparation and localization
• Gap analysis and regulatory strategy
• Cybersecurity and post-market compliance advisory
• Factory audit and certification support

With our deep understanding of Brazilian regulatory frameworks, we streamline your product’s path to approval while ensuring full compliance and global readiness.

 Conclusion

The Brazilian medical device market offers immense growth potential — but only for companies that master the inmetro certification process.
 From ISO-based QMS verification to cybersecurity compliance and technical documentation accuracy, every step plays a vital role in achieving regulatory success.

By collaborating with Maven Regulatory Solutions, manufacturers can simplify certification, accelerate market entry, and stay compliant with Brazil’s evolving regulatory standards in 2025 and beyond.